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[口服给予β2 激动剂克伦特罗和沙丁胺醇后震颤ogenic 效应的新型定量评估]

[Novel quantitative assessment of the tremorogenic effects of the beta 2-mimetics clenbuterol and salbutamol after oral administration].

作者信息

Schaffler K, Schuster D

出版信息

Arzneimittelforschung. 1985;35(8):1299-302.

PMID:3907640
Abstract

A pharmacodynamic study was run in 12 healthy volunteers (4 male, 8 female, mean age 33.3 years, mean body-weight 60.8 kg) to demonstrate a dose- and time-effectiveness dependency for a beta 2-mimetic drug (clenbuterol, Spiropent) versus salbutamol and placebo as reference. A newly developed 3-dimensional tremormeter was introduced in this randomised double-blind/6-way/cross-over study. The shape of the induced tremor effects (in amplitude) as well as the pulse frequency reflected highly significant dose relationships. Drug effects started 30 min after intake and lasted longer than 600 min. 10 micrograms of clenbuterol revealed no significant differences when compared to placebo, whereas the 20 micrograms dosage as usually administered in clinical routine demonstrated significant--but only slight--differences to placebo-baseline. All other dosages and the reference (salbutamol, 8 mg) could be discriminated distinctly against placebo.

摘要

在12名健康志愿者(4名男性,8名女性,平均年龄33.3岁,平均体重60.8千克)中进行了一项药效学研究,以证明一种β2-拟交感神经药物(克仑特罗, Spiropent)相对于作为对照的沙丁胺醇和安慰剂的剂量和时间效应依赖性。在这项随机双盲/六路交叉研究中引入了一种新开发的三维震颤仪。诱发震颤效应的形状(幅度)以及脉搏频率反映出高度显著的剂量关系。药物效应在摄入后30分钟开始,持续超过600分钟。与安慰剂相比,10微克克仑特罗无显著差异,而临床常规使用的20微克剂量与安慰剂基线相比有显著差异,但差异较小。所有其他剂量和对照(8毫克沙丁胺醇)与安慰剂有明显区别。

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